Statement on the derivation of Health‐Based Guidance Values (HBGVs) for regulated products that are also nutrients

More, Simon J.; Bampidis, Vasileios; Benford, Diane; Bragard, Claude; Halldórsson, Thorhallur I.; Bennekou, Susanne Hougaard; Koutsoumanis, Kostas; Machera, Kyriaki; Naegeli, Hanspeter; Nielsen, Søren Saxmose; Schlatter, Josef Rudolf; Schrenk, Dieter; Silano, Vittorio; Turck, Dominique; Younes, Maged; Aggett, Peter; Castenmiller, Jacqueline; Giarola, Alessandra; Sesmaisons‐Lecarré, Agnès de; Tarazona, José; Verhagen, Hans; Hernández‐Jerez, Antonio F

doi:10.2903/j.efsa.2021.6479

Cited by 26 publications

(27 citation statements)

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“…Two major features of dietary guidance for n -3 PUFAs consumption are the absolute amount of n -3 PUFAs intake and the n -6/ n -3 ratio as adequate intake (AI) ( Table 4 ). Guidelines from Korea [ 74 ], the US [ 75 ], the European Food Safety Authority (ESFA) [ 76 ], and China [ 77 ] suggest AI levels for either n -3 or n -6 PUFAs. Korean [ 74 ] and American guidelines [ 75 ] designate the consumption amounts for linoleic acid (10–13 and 11–17 g/day for Korean and American guidelines, respectively) and α-linolenic acid (1.2–1.6 and 1.1–1.6 g/day for Korean and American guidelines, respectively).…”

Section: Discussionmentioning

confidence: 99%

“…Korean [ 74 ] and American guidelines [ 75 ] designate the consumption amounts for linoleic acid (10–13 and 11–17 g/day for Korean and American guidelines, respectively) and α-linolenic acid (1.2–1.6 and 1.1–1.6 g/day for Korean and American guidelines, respectively). Moreover, guidelines from Korea [ 74 ] and ESFA [ 76 ] recommend AI levels for the sum of EPA and DHA (≥150 mg/day for Korean and 250 mg/day for ESFA guidelines). In addition, some guidelines suggest a recommended ratio of n -6/ n -3 PUFAs: guidelines from Korea [ 74 ] and the US [ 75 ] are 4–10 and ~3, respectively.…”

Section: Discussionmentioning

confidence: 99%

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Lowering n-6/n-3 Ratio as an Important Dietary Intervention to Prevent LPS-Inducible Dyslipidemia and Hepatic Abnormalities in ob/ob Mice

Park

Lee

et al. 2022

IJMS

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Obesity is closely associated with low-grade chronic and systemic inflammation and dyslipidemia, and the consumption of omega-3 polyunsaturated fatty acids (n-3 PUFAs) may modulate obesity-related disorders, such as inflammation and dyslipidemia. An emerging research question is to understand the dietary intervention strategy that is more important regarding n-3 PUFA consumption: (1) a lower ratio of n-6/n-3 PUFAs or (2) a higher amount of n-3 PUFAs consumption. To understand the desirable dietary intervention method of n-3 PUFAs consumption, we replaced lard from the experimental diets with either perilla oil (PO) or corn oil (CO) to have identical n-3 amounts in the experimental diets. PO had a lower n-6/n-3 ratio, whereas CO contained higher amounts of PUFAs; it inherently contained relatively lower n-3 but higher n-6 PUFAs than PO. After the 12-week dietary intervention in ob/ob mice, dyslipidemia was observed in the normal chow and CO-fed ob/ob mice; however, PO feeding increased the high density lipoprotein-cholesterol (HDL-C) level; further, not only did the HDL-C level increase, the low density lipoprotein-cholesterol (LDL-C) and triglyceride (TG) levels also decreased significantly after lipopolysaccharide (LPS) injection. Consequently, extra TG accumulated in the liver and white adipose tissue (WAT) of normal chow- or CO-fed ob/ob mice after LPS injection; however, PO consumption decreased serum TG accumulation in the liver and WAT. PUFAs replacement attenuated systemic inflammation induced by LPS injection by increasing anti-inflammatory cytokines but inhibiting pro-inflammatory cytokine production in the serum and WAT. PO further decreased hepatic inflammation and fibrosis in comparison with the ND and CO. Hepatic functional biomarkers (aspartate aminotransferase (AST) and alanine transaminase (ALT) levels) were also remarkably decreased in the PO group. In LPS-challenged ob/ob mice, PO and CO decreased adipocyte size and adipokine secretion, with a reduction in phosphorylation of MAPKs compared to the ND group. In addition, LPS-inducible endoplasmic reticulum (ER) and oxidative stress decreased with consumption of PUFAs. Taken together, PUFAs from PO and CO play a role in regulating obesity-related disorders. Moreover, PO, which possesses a lower ratio of n-6/n-3 PUFAs, remarkably alleviated metabolic dysfunction in LPS-induced ob/ob mice. Therefore, an interventional trial considering the ratio of n-6/n-3 PUFAs may be desirable for modulating metabolic complications, such as inflammatory responses and ER stress in the circulation, liver, and/or WAT.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Lowering n-6/n-3 Ratio as an Important Dietary Intervention to Prevent LPS-Inducible Dyslipidemia and Hepatic Abnormalities in ob/ob Mice

Park

Lee

et al. 2022

IJMS

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“…In this Opinion, the health‐based guidance value (HBGV) for chronic copper exposure is re‐evaluated according to the EFSA proposed harmonised approach for establishing HBGVs for substances that are regulated products and also nutrients (henceforth ‘EFSA Statement on HBGV’) (EFSA Scientific Committee, 2021 ). This re‐evaluation is based on existing assessments (WHO, 1996 ; IPCS, 1998 ; IOM, 2001 ; EVM, 2003 ; SCF, 2003 ; ATSDR, 2004 ; France, 2007a , 2017 ; EFSA, 2008 , 2018b ; VKM, 2017 ) and additional relevant literature.…”

Section: Introductionmentioning

confidence: 99%

Re‐evaluation of the existing health‐based guidance values for copper and exposure assessment from all sources

More¹,

Bampidis²,

Benford³

et al. 2023

EFS2

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Copper is an essential micronutrient and also a regulated product used in organic and in conventional farming pest management. Both deficiency and excessive exposure to copper can have adverse health effects. In this Scientific Opinion, the EFSA 2021 harmonised approach for establishing health‐based guidance values (HBGVs) for substances that are regulated products and also nutrients was used to resolve the divergent existing HBGVs for copper. The tightly regulated homeostasis prevents toxicity manifestation in the short term, but the development of chronic copper toxicity is dependent on copper homeostasis and its tissue retention. Evidence from Wilson disease suggests that hepatic retention is indicative of potential future and possibly sudden onset of copper toxicity under conditions of continuous intake. Hence, emphasis was placed on copper retention as an early marker of potential adverse effects. The relationships between (a) chronic copper exposure and its retention in the body, particularly the liver, and (b) hepatic copper concentrations and evidence of toxicity were examined. The Scientific Committee (SC) concludes that no retention of copper is expected to occur with intake of 5 mg/day and established an Acceptable Daily Intake (ADI) of 0.07 mg/kg bw. A refined dietary exposure assessment was performed, assessing contribution from dietary and non‐dietary sources. Background copper levels are a significant source of copper. The contribution of copper from its use as plant protection product (PPP), food and feed additives or fertilisers is negligible. The use of copper in fertilisers or PPPs contributes to copper accumulation in soil. Infant formula and follow‐on formula are important contributors to dietary exposure of copper in infants and toddlers. Contribution from non‐oral sources is negligible. Dietary exposure to total copper does not exceed the HBGV in adolescents, adults, elderly and the very elderly. Neither hepatic copper retention nor adverse effects are expected to occur from the estimated copper exposure in children due to higher nutrient requirements related to growth.

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“…In considering biological plausibility of NMDRs, the Working Group noted that nutrients, particularly vitamins, minerals and trace elements, represent a specific case, in which an overall U‐shaped curve is expected for some effects. At the lower end of the dose‐response relationship, deficiency of the nutrient leads to adverse effects, whereas toxicity may occur at higher doses ( IPCS, 2002 ; EFSA Scientific Committee, 2021 ). In such cases, the NMDR is explained by two distinct but overlapping biological processes, which existing risk assessment paradigms can easily address.…”

Section: Introductionmentioning

confidence: 99%

“…In such cases, the NMDR is explained by two distinct but overlapping biological processes, which existing risk assessment paradigms can easily address. IPCS ( ‎2002 ) and EFSA Scientific Committee ( 2021 ) refer to an Acceptable Range of Oral Intake (AROI) for essential nutrients, bounded by rising risks of either deficiency, as intake declines, or toxicity as intake increases. As this is a well‐known situation fully integrated in EFSA assessments, no further considerations regarding nutrients are included in this Opinion.…”

Section: Introductionmentioning

confidence: 99%

Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments

More¹,

Benford²,

Bennekou³

et al. 2021

EFS2

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This Opinion assesses the biological relevance of the non‐monotonic dose responses ( NMDR ) identified in a previous EFSA External Report (Beausoleil et al., 2016) produced under GP / EFSA / SCER /2014/01 and the follow‐up probabilistic assessment (Chevillotte et al., 2017a,b), focusing on the in vivo data sets fulfilling most of the checkpoints of the visual/statistical‐based analysis identified in Beausoleil et al. (2016). The evaluation was completed with cases discussed in EFSA assessments and the update of the scientific literature. Observations of NMDR were confirmed in certain studies and are particularly relevant for receptor‐mediated effects. Based on the results of the evaluation, the Opinion proposes an approach to be applied during the risk assessment process when apparent non‐monotonicity is observed, also providing advice on specific elements to be considered to facilitate the assessment of NMDR in EFSA risk assessments. The proposed approach was applied to two case studies, Bisphenol A and bis(2‐ethylhexyl phthalate ( DEHP ) and these evaluations are reported in dedicated annexes. Considering the potential impact of NMDR s in regulatory risk assessment, the Scientific Committee recommends a concerted international effort on developing internationally agreed guidance and harmonised frameworks for identifying and addressing NMDR s in the risk assessment process.

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Statement on the derivation of Health‐Based Guidance Values (HBGVs) for regulated products that are also nutrients

Cited by 26 publications

References 50 publications

Lowering n-6/n-3 Ratio as an Important Dietary Intervention to Prevent LPS-Inducible Dyslipidemia and Hepatic Abnormalities in ob/ob Mice

Lowering n-6/n-3 Ratio as an Important Dietary Intervention to Prevent LPS-Inducible Dyslipidemia and Hepatic Abnormalities in ob/ob Mice

Re‐evaluation of the existing health‐based guidance values for copper and exposure assessment from all sources

Opinion on the impact of non‐monotonic dose responses on EFSA′s human health risk assessments

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